Quality/GMPs

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.

The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.

Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

The agency granted Pfizer, Cellectis, and Servier clearance to begin clinical development with UCART19.

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.

The agency sent a warning letter to Chongqing Pharma Research Institute Co., Ltd. citing data integrity violations.

Dr. Janet Woodcock said implementation of Informatics Process Management is a priority during the latest Director’s Corner podcast.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

President Trump calls for faster FDA approvals and lower drug prices.

Drug type, potential sales, and ownership factor in the race to get drugs to market.

Manufacturers face uncertainty over imports, regulatory policies, and field inspections.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.

Moving global manufacturing operations may be more complicated than it appears.

As the November 2017 deadline nears, a surprising number of companies still don’t have a serialization plan in place. New programs aim to get them compliant in time.

Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall laboratory efficiency.

The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.

FDA plans to initiate its quality metrics program as industry continues to push back.

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.